Documents considered by the Committee on 22 January 2014 - European Scrutiny Committee Contents

3 Animal cloning




+ ADDs 1-2

COM(13) 892




COM(13) 893

Draft Directive on the cloning of animals of the bovine, porcine, ovine, caprine and equine species kept and reproduced for farming purposes

Draft Council Directive on the placing on the market of food from animal clones

Legal base (a) Article 43(2) TFEU; c o-decision; QMV

(b) Article 352(1); consent; unanimity

Document originated 18 December 2013
Deposited in Parliament 31 December 2013
Department Environment, Food and Rural Affairs
Basis of consideration EM of 14 January 2014
Previous Committee Report None; but see footnote 23
Discussion in Council No date set
Committee's assessment Legally and politically important
Committee's decision Not cleared; further information requested


3.1 Cloning[22] is a relatively new breeding technique which allows for the asexual reproduction of animals which have shown good productivity, low incidence of disease and the ability to cope with the production environment, and has been the subject of extensive discussion within the EU. In particular, the Commission produced in October 2010 a report[23] which sought to assess the technology as it applies to food production, looking at such aspects as food safety and the health and welfare of the animals, as well as the ethical and trade implications and the rights of consumers.

3.2 It concluded that, whilst it is scientifically accepted that there are no food safety concerns about food produced from clones or their offspring, the animal welfare[24] risks provide a solid basis for it to initiate legislation. After identifying a range of options — including preserving the legal status quo; a total prohibition on the cloning of farm animals for food on EU territory, on the use of clones and on the placing on the market of food from them, including imports; on the placing on the market of the offspring of clones and food arising from such offspring, and on the use of reproductive material from clones — it said that it would propose to:

·  suspend temporarily the use of the technique in the EU for the reproduction of all food producing animals, the use of clones of these animals, and the marketing of food from clones; and

·  establish the traceability of imports of semen and embryos to allow farmers and industry to set up data banks of offspring in the EU.

3.3 It adds that the measure would be based subject to review after five years, and that cloning would remain possible for all purposes other than food production (such as research, the production of pharmaceuticals, and the conservation of endangered species or breeds).

3.4 As we noted in our Report of 24 November 2010, the Government recognises that cloning is not a traditional breeding technique, and the need to safeguard food safety and consumer choice (for example, by approval having to be sought under the Novel Foods Regulation (258/97) before food from clones themselves can be marketed). However, whilst also recognising that the welfare of clones and their surrogate dams needs to be protected, it believes that existing EU legislation is sufficient to deal with welfare issues. In particular, it was opposed to a ban, or temporary prohibition, on cloning, the use of clones and the marketing of food from clones as being disproportionate in terms of food safety and animal welfare, and said that, although a temporary ban on the use of cloning techniques within the EU would have little impact in the UK, as there are no companies here currently offering a commercial cloning service, it was important not to deny to UK industry technology which is available elsewhere in the world, and which could be useful in bringing about more rapid access to desirable traits, including resistance to disease.

3.5 We commented that, compared with many similar documents, this was a well presented report, which dealt in a balanced and sensible manner with a range of issues arising on what is evidently a topic of undoubted public interest. However, we noted the Government's reservations about aspects of the immediate course of action proposed by the Commission, and, in view of this, we recommended the report for debate in European Committee A. That debate duly took place on 31 January 2011.

The current documents

3.6 The Commission has now brought forward these two draft Directives, which would respectively:

·  prohibit the commercial cloning of traditionally farmed species (cattle, sheep pigs, goats and horses), and the placing on the market of animal clones and embryo clones (document (a)); and

·  require Member States to prevent food from animal clones from being placed on the market, and to ensure that food of animal origin imported from third countries where food from clones can be legally placed on the market or is exported is only placed on the EU market where it can be established that it does not derive from animal clones (document (b)).

3.7 However, the proposals will allow the continuation of the use of reproductive material from clones for livestock breeding purposes; for scientific research into cloning and its use for the preservation of rare breeds or endangered species; and for sporting or cultural events.

The Government's view

3.8 In his Explanatory Memorandum of 14 January 2014, the Parliamentary Under-Secretary of State at the Department for Environment, Food and Rural Affairs (George Eustice) says that the absence of any commercial cloning activity in the UK (or EU) at present, means that a ban on the practice will have no direct consequences for UK business. Addressing the question of subsidiarity compliance, the Government does not believe that either of the proposals is necessary, given the absence of human health concerns associated with cloning and the protection already offered by the existing EU animal welfare and novel foods regime, but nevertheless considers that if there have to be controls put in place, these must be done consistently at EU level.

3.9 The Minister adds that the available science (including that from the European Food Safety Authority (EFSA)) is clear that milk and meat from clones and their offspring is no more harmful than that from traditionally reared animals, and that, although the proposals aim to address welfare concerns specifically surrounding the currently low efficacy of cloning, and the resulting dam health complications and offspring mortality, the Government believes — and the Commission acknowledges — that the wellbeing of the animals concerned is already generally protected by existing national and EU animal welfare rules.

3.10 The Minister also observes that the timing of the proposals is problematic, since they coincide with negotiations between the EU and both the US and Mercosur countries[25] concerning bilateral trade agreements. He points out that these countries already trade animal products freely, with no record of whether they are derived from clones or not, and that, depending on the final outcome of negotiations, the proposals could be tantamount to a trade ban, and thus eventuality have significant repercussions for both the EU and UK, who currently benefit from sizeable trade flows in both directions, if (as seems likely) they give rise to retaliatory action.

3.11 In addition, they would have the potential to generate a challenge within the World Trade Organisation (WTO) should the principles enshrined in the sanitary and phytosanitary agreement be breached: and, since no records are kept of individual cloning activity, the requirement to trace consignments of cloned animals or cloned material would currently be impossible to enforce, place significant regulatory and financial burdens on UK farmers, food producers and taxpayers, and would not, in any case, address the issue of products already present in the EU.

3.12 The Minister says that an EU Checklist will be prepared once the relevant interested parties have consulted on the detail of the proposals, and he hopes that this can be made available by the beginning of July. However, he also comments that, because of the particular sensitivities surrounding the subject of cloning, neither the Commission nor the Greek Presidency are expected to fast-track approval of the proposals, with discussions at Council Working Group level not beginning until the end of February. Also, given the impending European Parliament elections, followed by the appointment of the new Commission, only limited progress is expected before September 2014.

Legal issues

3.13 There are, additionally, several legal issues on which the Minister comments. He identifies that the proposals may interfere with the fundamental freedom to conduct a business (Article 16 of the Charter). The Minister also says that since the Government does not consider that the proposals are necessary, it has some concerns that interference with the right may be unwarranted. However, citing the Sky Österreich[26] judgment and other ECJ cases, the Minister recognises that the Court considers that a "broad range of reasons could justify intereference right" and that it seemed likely that "a Court would be receptive to the arguments presented by the Commission".

3.14 The Minister also identifies that as the legal base for document (b) is Article 352(1) TFEU, primary legislation will be required before the UK Government can support or approve the proposal pursuant to section 8 of the European Union Act 2011.


3.15 It would appear that these proposals mirror closely those canvassed in the report produced by the Commission in 2010, which was debated in European Committee A in January 2011, and that — not surprisingly — the view taken by the Government remains similar to that we reported to the House on 24 November 2010. Consequently, although the subject of animal cloning continues to be of some public interest, we do not see any immediate need for a further debate (although we may well do so at a later stage as the negotiations unfold, and the implications — including those for the EU's bilateral trade agreements — become clearer).

3.16 In the meantime, we think it right to draw these proposals to the attention of the House, but to hold them under scrutiny pending further developments, including the preparation of an EU checklist (though we note that only limited progress is expected before this autumn). We also ask the Minister to respond, in time for consideration at our meeting on 29 January, to the following points:

i)  noting that the subsidiarity deadline on both proposals is 17 February, how the Government can conclude that EU level action is justified if it considers legislative action is not necessary in the first place and therefore that the pre-requisite for subsidiarity compliance is not met;

ii)  whether the Government has satisfied itself that the use of Article 352 TFEU by the Commission in respect of document (b) is justified and the reasons for this; and

iii)  whether the Government has considered the arguments relating to proportionality in concluding that it is likely that the Court of Justice would not find the proposed legislation was incompatible with Article 16 of the Charter of Fundamental Rights.

22   Cloning is defined as replication by somatic cell nuclear transfer to create genetic replicas. The report does not cover embryo splitting or any form of genetic modification. Back

23   See (32117) 15277/10: HC 428-ix (2010-11), chapter 1 (24 November 2010). Back

24   These include the large number of cloned embryos which fail to develop to term, the significant proportion which die during (or shortly after) birth; the adverse on surrogate cattle dams; and the tendency for cloned cattle and sheep to be unusually large. Back

25   Argentina, Brazil, Paraguay, Uruguay and Venezuela. Back

26   Case C-283/11 Sky Österreich, judgment of 22 January 2013, para 46. See also Case C-348/12P Kala Naft, judgment of 28 November 2013, para 123; Case C-390/12 Pfleger, Advocate General's Opinion, para 70. Back

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Prepared 5 February 2014